GSK seeks to market world's first malaria vaccine

GSK intends to apply for regulatory approval to European Medicines Agency (EMA) in 2014 after trial results showed that malaria vaccine candidate RTS,S, reduced the deaths of children dying from malaria by half. Photo/FILE 

By Evelyn Situma

IN SUMMARY
According to the trial results, malaria vaccine candidate RTS,S, reduced the deaths of children dying from malaria by half.
The findings, have now led GSK and MVI, to believe the vaccine is the best supplement to existing tools used to fight against the parasitic disease.
GSK intends to apply for regulatory approval to European Medicines Agency (EMA) next year, a move the World Health Organisation says if fruitful may earn GSK a policy recommendation in 2015.
     
British drug maker GlaxoSmithKline (GSK) has recorded great success on the world's first malaria vaccine after years of trial, opening up an opportunity for commercialisation.

GSK, which made the announcement on the progress at a health conference in South Africa on Tuesday, says it intends to apply for regulatory approval to European Medicines Agency (EMA) next year, a move the World Health Organisation says if fruitful may earn GSK a policy recommendation in 2015.

“Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). This marks a significant step forward in the development of the vaccine candidate,” said GSK chief executive, Sir Andrew Witty.

According to the trial results, malaria vaccine candidate RTS,S, reduced the deaths of children dying from malaria by half.  On infants, the vaccine cut down the deaths by 25 per cent. This gives a sigh of relief to Bill & Melinda Gates, given they had first expressed their frustration last year during the first release of the data from Phase III trial. However, GSK and PATH Malaria Vaccine Initiative (MVI) remained optimistic and it now seems their optimism is finally paying off. Bill & Melinda Gates funded the research through MVI.

READ: World’s first malaria vaccine performs poorly after tests on babies

The research further points out that the vaccine continued to protect young children and infants from clinical malaria up to 18 months after vaccination during trial.

“These latest results demonstrated that over 18 months of follow-up, RTS,S was shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination),” reads the report on the trial results.

The findings, have now led GSK and MVI, to believe the vaccine is the best supplement to existing tools used to fight against the parasitic disease.

“We’re very encouraged by these latest results, which show that RTS,S continued to provide meaningful protection over 18 months to babies and young children across different regions of Africa,” said Sir Witty.

Although the vaccine continues to record decline in efficacy, researchers remain optimistic.

“While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means the number of cases of the disease the vaccine can help prevent is impressive,” added Sir Witty.

Malaria kills 600, 000 children annually in sub-Saharan Africa, it is hoped with the vaccine, more lives will be saved. Currently, insecticide treated nets and indoor residual sprays are used for preventative measures.

They have so far curtailed malaria deaths in Kenya by 10,000 according to data on the disease from Kenya National Bureau of Statistics.